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Migraine Prophylaxis With Clopidogrel Trial

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified October 2016 by First Affiliated Hospital Xi'an Jiaotong University
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier:
NCT02938182
First received: October 17, 2016
Last updated: NA
Last verified: October 2016
History: No changes posted
  Purpose
The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine may concern with platelet aggregation and paradoxical embolization. The aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.

Condition Intervention Phase
Migraine Drug: clopidogrel Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Trial to Evaluate the Effectiveness of Clopidogrel to Relieve Migraine With Right-to-left Shunt

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital Xi'an Jiaotong University:

Primary Outcome Measures:
  • Change from Baseline Attack Duration of Headache at three months, h [ Time Frame: three months ]

Secondary Outcome Measures:
  • Change from Baseline Headache Frequency per Month at three months, time [ Time Frame: three months ]
  • Change from Baseline Visual Analogue Scale at three months, scores [ Time Frame: three months ]
  • Change from Baseline Migraine Disability Assessment Scale at three months, scores [ Time Frame: three months ]
  • Change from Baseline Headache Impact Test at three months, scores [ Time Frame: three months ]

Estimated Enrollment: 50
Study Start Date: October 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: clopidogrel
clopidogrel tablet 75mg daily for three months
Drug: clopidogrel
clopidogrel troche 75 mg daily for three months
Other Name: plavix

Detailed Description:
Many studies have shown an increased prevalence of right-to-left shunts in migraineurs. The underlying mechanisms of association between the right-to-left shunts (RLS) and migraine may concern with platelet aggregation and paradoxical embolization. In the present study, migraineurs without taking prophylactic medicines regularly will be given only clopidogrel 75 mg daily for three months. Migraineurs who are unresponsive to at least two commonly applied preventive medications, clopidogrel 75 mg daily will be added to his/her existing prophylactic migraine regimen for three months. Patients will be followed up at the third month and the sixth month for headache frequency, attack duration of headache, migraine disability assessment scale(MIDAS)scores, headache impact test(HIT-6)scores and visual analogue scale(VAS)scores. Investigators will evaluate the changes of these measurements between baseline and the follow-up time. The aim of the study is to evaluate the prophylactic effectiveness of clopidogrel for migraineurs with RLS.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • migraine with or without aura diagnosed by a neurologist according to the criteria of the International Headache Society (3nd edition)
  • experience a minimum of two migraine attacks per month in a 3-month baseline phase
  • without regular use of prophylactic treatments or unresponsive to two and more commonly applied preventive medications
  • the presence of RLS confirmed by contrast-enhanced transcranial Doppler
  • no positive findings in cranial CT and MRI

Exclusion Criteria:

  • other types of headaches
  • systemic chronic diseases, cerebrovascular disease, abnormal platelet or liver function
  • history of head injury
  • other contraindications to clopidogrel treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02938182

Contacts
Contact: Guogang Luo, doctor 0086-13991974085 lguogang@163.com
Contact: Dan Zhu, master 0086-15229233307 767441726@qq.com

Locations
China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Not yet recruiting
Xi'an, Shaanxi, China, 710061
Contact: Guogang Luo, doctor    0086-13991974085    lguogang@163.com   
Contact: Dan Zhu, master    0086-15229233307    767441726@qq.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
Principal Investigator: Guogang Luo, doctor First Affiliated Hospital Xi'an Jiaotong University
  More Information

Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02938182     History of Changes
Other Study ID Numbers: XJTU1AF-CRS-2016-019
Study First Received: October 17, 2016
Last Updated: October 17, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The information of the patients need to keep confidential.

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Clopidogrel
Ticlopidine
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017